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Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bilateral Abdominal Sacral Hysteropexy
Conventional abdominal Sacral Hysteropexy
Nulliparous women with no uterovaginal prolapsed
Sponsored by
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women with stage 3 or more pelvic organ prolapse

Exclusion Criteria:

  • Women with abnormal uterine bleeding, abnormal cervical screening test, myoma uteri and want to hysterectomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Bilateral Abdominal Sacral Hysteropexy

    Classic Abdominal Sacral Hysteropexy

    Women with no uterovaginal prolapsed

    Arm Description

    Bilateral abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.

    Conventional abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.

    Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.

    Outcomes

    Primary Outcome Measures

    Anatomic Success
    anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane

    Secondary Outcome Measures

    Full Information

    First Posted
    January 21, 2016
    Last Updated
    March 13, 2022
    Sponsor
    Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02667002
    Brief Title
    Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy
    Official Title
    Randomized Single Blind Controlled Trial of Comparison of Anatomic and Sexual Outcomes Between Conventional and Bilateral Sacral Hysteropexy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zeynep Kamil Maternity and Pediatric Research and Training Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Investigators separated 20 patients with uterovaginal prolapse into 2 groups according to random numbers table. In one group, conventional abdominal sacral hysteropexy will be perform and another group bilateral abdominal sacral hysteropexy will be perform with polypropylene mesh. After 1 mont operation vaginal configuration will be evaluate with MRI on three plane (axial, sagittal, coronal). Then the results of thus two groups will be compare to results of nullipara patients. Investigators will investigate which technique keep the vaginal axis is closer to the original anatomic position.
    Detailed Description
    Since vaginal hysterectomy and mc call culdoplasty, many techniques have been described. Before, correcting only prolapsed part, now, we can measure anatomical and functional results more objectively by using different tool such us MRI, perineal ultrasonography, PISQ-12, IIQ-7 (Incontinence impact questionnaire). Hence pelvic organ prolapse surgery is important in terms of anatomic and functional results. Unilateral abdominal sacral hysteropexy can put vaginal axis to right side slightly. Therefore investigators hypothesized that bilateral sacral hysteropexy which mimic sacrouterine ligament can be more suitable in terms of anatomic results.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Organ Prolapse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bilateral Abdominal Sacral Hysteropexy
    Arm Type
    Experimental
    Arm Description
    Bilateral abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.
    Arm Title
    Classic Abdominal Sacral Hysteropexy
    Arm Type
    Experimental
    Arm Description
    Conventional abdominal sacral hysteropexy will be perform in 10 patients. One month after patients will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.
    Arm Title
    Women with no uterovaginal prolapsed
    Arm Type
    Active Comparator
    Arm Description
    Ten nulliparous participants with no uterovaginal prolapsed will be evaluate by MRI and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) form.
    Intervention Type
    Procedure
    Intervention Name(s)
    Bilateral Abdominal Sacral Hysteropexy
    Intervention Description
    The mesh will be fixed right and left side of sacrum.
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional abdominal Sacral Hysteropexy
    Intervention Description
    The mesh will be fixed only right side of sacrum
    Intervention Type
    Other
    Intervention Name(s)
    Nulliparous women with no uterovaginal prolapsed
    Intervention Description
    This will be control group which consistent patients with no uterovaginal prolapse.
    Primary Outcome Measure Information:
    Title
    Anatomic Success
    Description
    anatomic success will be evaluated by using magnetic resonance imaging. Vaginal axis (distance to spin ischiadic a and sacrum) will be measure on three plane
    Time Frame
    One month

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women with stage 3 or more pelvic organ prolapse Exclusion Criteria: Women with abnormal uterine bleeding, abnormal cervical screening test, myoma uteri and want to hysterectomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mehmet Baki Şentürk, MD
    Organizational Affiliation
    Zeynep Kamil Maternity and Pediatric Research and Training Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data will be available within 1 week of study completion.
    Citations:
    PubMed Identifier
    22890409
    Citation
    Jager W, Mirenska O, Brugge S. Surgical treatment of mixed and urge urinary incontinence in women. Gynecol Obstet Invest. 2012;74(2):157-64. doi: 10.1159/000339972. Epub 2012 Aug 9.
    Results Reference
    result
    PubMed Identifier
    11795640
    Citation
    Sze EH, Meranus J, Kohli N, Miklos JR, Karram MM. Vaginal configuration on MRI after abdominal sacrocolpopexy and sacrospinous ligament suspension. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):375-9; discussion 379-80. doi: 10.1007/s001920170016.
    Results Reference
    result
    PubMed Identifier
    25961042
    Citation
    Joukhadar R, Meyberg-Solomayer G, Hamza A, Radosa J, Bader W, Barski D, Ismaeel F, Schneider G, Solomayer E, Baum S. A Novel Operative Procedure for Pelvic Organ Prolapse Utilizing a MRI-Visible Mesh Implant: Safety and Outcome of Modified Laparoscopic Bilateral Sacropexy. Biomed Res Int. 2015;2015:860784. doi: 10.1155/2015/860784. Epub 2015 Apr 19.
    Results Reference
    result
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/22890409
    Description
    pubmed
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/25961042
    Description
    pubmed
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/?term=Vaginal+Configuration+on+MRI+after+Abdominal+Sacrocolpopexy+and+Sacrospinous+Ligament+Suspension
    Description
    pubmed

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    Comparison of Anatomic Results Between Bilateral and Conventional Abdominal Sacral Hysteropexy

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